Opportunity to Job as a Senior Manager / Team Leader @ Pfizer

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post: Senior Manager / Team Leader

Job Description:
Purpose and Scope:
The incumbent and his/her staff will have total accountability for the quality of contract manufactured products, and compliance of Pfizer contract manufacturers in India. This includes providing quality assurance leadership to manage vendor issues arising at contract manufacturing sites, developing, implementing and maintaining fit-for-purpose quality systems for ongoing quality oversight of these contractors. The Senior Manager /Team Leader will manage a staff of colleagues that may include Executives, Assistant Managers and Managers.
Reporting to: Director, COQA India

Key Responsibilities:
Manage overall quality oversight of all contractors in India
Provide quality assurance leadership to manage complex quality and compliance issues arising at the contract manufacturing sites
Lead the development and negotiation of quality and technical agreements with contractors and user sites; ensure applicable quality provisions of supply and contract manufacturing agreements meet Pfizer requirements
Provide leadership to the establishment and implementation of fit-for-purpose quality systems at contract manufacturing sites in India for Pfizer products and non-Pfizer molecules
Help support in due diligence assessments of new contract manufacturers
cGMP assessments of contract manufacturers
Provide support to QO leadership in new products launches
Provide support to QO leadership in product and technology transfer projects
Support development, implementation and maintenance of internal quality systems within COQA
Support SLS surveillance testing issue resolution, and provide leadership to the troubleshooting of product quality, cGMP and regulatory compliance issues at contractors
Represent COQA in India with internal and external stakeholders on quality and compliance issue resolution
QO interface on business teams managing contractors in India

Candidate Profile:
Educational / Experience Required :
A minimum of a Master’s degree in Microbiology, Chemistry, Pharmacy or related science

Other Job Related Requirements :
A minimum of 15 years experience in the pharmaceutical industry with 10+ years relevant site or external QA/QC/Manufacturing experience
Demonstrated management/organizational skills with at least 7 years of supervisory experience
Extensive knowledge of the FD&C Act, cGMP, ICH guidelines, and international regulations for pharmaceutical products
Demonstrated skills in operational planning, organizational effectiveness, integrating and coordinating with related units and work processes
Demonstrated experience in managing complex quality and compliance issues in a manufacturing plant or at a contract manufacturing site
Must have excellent communication skills
Demonstrated trustworthiness, cooperation and flexibility interacting with many different organizations internally and externally
Demonstrated leadership capabilities, accountability, and ability to resolve conflict
Familiarity with Indian pharmaceutical regulatory requirements and Indian culture; good Hindi language skills required
This role will provide support to GES-Asia Regional Leader regarding supply initiatives in India. The Senior/Team Leader will interact with the management staff at vendor sites and within Pfizer. He/she will have interactions with many internal business and manufacturing organizations (e.g., GES, OpUs, Pfizer Country Offices, GMS, GCMC, and PGRD), and provide leadership to cross-functional teams such as Co-Development Teams and New Product Introduction Teams, representing QO. Travel up to 40% is expected.

Additional Information:
Experience: Min. 15 Years
Location: India
Education: M.Pharm, M.Sc-Microbiology, Chemistry
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA, QC, Production
Job ID: 951430